Byetta

Author P. Bansal from the Division of Gastroenterology at the Department of Veterans Affairs Medical Center in Milwaukee, Wisconsin, conducted a study called “Pancreatitis is a Risk Factor For Pancreatic Cancer”, where the main goal was to determine if pancreatitis is a risk factor for pancreatic cancer. Information for this study was obtained from the Department of Veteran Affairs, which maintains a computerized file of hospital discharges since 1970.

First, a little background. Pancreatitis is inflammation in the pancreas. This organ produces enzymes that help digestion and hormones that help with the regulation of processing sugars in the body, and chronic pancreatitis (prolonged inflammation of the pancreas) has been associated with an elevated risk of developing pancreatic cancer. Some mild cases of pancreatitis may go away without treatment, however chronic pancreatitis may be life-threatening.

The Bansal study was a case-control study that compared the prevalence of pancreatitis in 2639 patients with pancreatic cancer. Data from this group was compared to a control group of 7,774 subjects. Bansal states “The odds ratio associated with pancreatitis increased from 2.04 (95% confidence interval [CI], 1.53-2.72) 7 or more years before the first diagnosis of cancer to 2.14 (CI, 1.68-2.72) 3 or more years before cancer diagnosis and to 2.31 (CI, 1.87-2.86) 1 or more years before cancer diagnosis.” In other words, this data shows that having pancreatitis places one at at least twice as likely to develop pancreatic cancer than if one did not suffer from pancreatitis.

Using statistics to evaluate the data collected more generally, Bansal found that all types of pancreatitis or chronic pancreatitis were connected with a significant risk for pancreatic cancer, the odd ratio for these were 3.42. (Having pancreatitis makes one more than three times as likely to later have pancreatic cancer.)

Because this study concluded that having pancreatitis increases the risk one faces for developing pancreatic cancer, it can be used in a GLP-1 therapy pancreatic cancer lawsuit. Recently, a number of diabetes drugs such as Byetta, Victoza, and Januvia (used in GLP-1 therapy for type-two diabetes) have been linked to a dramatically increased risk for pancreatitis. Because pancreatitis is connected to pancreatic cancer, drugs that are connected to pancreatitis should also include warnings about the risk for pancreatic cancer. Due to the fact that the manufacturers of drugs like exenatide (Byetta, Bydureon), liraglutide (Victoza), and sitagliptin (Januvia, Janumet, Janumet XR, Juvisync) have failed time and again to include adequate warnings about pancreatic cancer, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits are currently being filed.

If you or used Byetta, Victoza, Januvia, or another GLP-1 therapy drug and suffered from pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation through a Byetta lawsuit, Victoza lawsuit, a Januvia lawsuit, or a GLP-1 therapy pancreatic cancer lawsuit. For a free, no-obligation case consultation, contact our team of Byetta lawyers, Victoza lawyers, Januvia lawyers, and GLP-1 therapy pancreatic cancer lawyers at the information provided below.

Recent studies have shown that there is a positive correlation between pancreatic inflammation and an increased risk of pancreatic cancer. While acute pancreatitis that appears suddenly and may last for only a few days may not put an individual at a higher risk for cancer, chronic pancreatitis may last for several years and is associated with an elevated risk for pancreatic cancer.

David C. Whitcomb, from the American Journal of Physiology – Gastrointestinal and Liver Physiology, wrote a report titled “Inflammation and Cancer V. Chronic Pancreatitis and Pancreatic Cancer”, where he states “the mutations associated with hereditary pancreatitis or cystic fibrosis are not found in sporadic pancreatic adenocarcinomas, suggesting that the effects are indirect by causing recurrent pancreatitis and chronic inflammation. The process of mutation accumulation and clonal expansion that is required for development of invasive pancreatic adenocarcinoma must therefore be accelerated in chronic pancreatitis to account for the high incidence of pancreatic cancer in these patients.”

Recently, several drugs used in GLP-1 therapy to treat type-two diabetes (Byetta, Victoza, Januvia, and others) have been linked to increased risk for pancreatitis. Since studies such as the one described above document the connection between pancreatitis and pancreatic cancer, one can conclude that the use of Byetta, Victoza, Januvia and similar medications places one at an increased risk for pancreatic cancer.

At your convenience, you may reach our offices by phone at (855) 452 – 5529 or by e-mail at justinian@dangerousdrugs.us. We have the experience, resources, and skills required to win the justice you deserve.

In 2011, M. Elashoff, from the Larry L. Hillblom Islet Research Center at David Geffen School of Medicine and Department of Biomathematics at University of California, Los Angeles, published a study titled “Pancreatitis, Pancreatic, and Thyroid Cancer with Glucagon like Peptide-1-based Therapies”, wherein concerns regarding risk for pancreatitis and pancreatic and thyroid cancers are explored. Glucagon like peptide-1-based therapy is a treatment that is gaining widespread use.

Dipeptidyl peptidase-4 inhibitors may cause cancer due to their ability to negatively affect immune function. The study examined the US Food and Drug Administration’s database for reports that showed negative events with dipeptidyl peptidase-4 inhibitor sitagliptin and the glucagon-like peptide-1 mimetic exenatide (Byetta). This information was from 2004-2009, and the control group of this study were adverse events connected with four other medications. The report was looking for rates of reported pancreatitis, pancreatic and thyroid cancer, and all other cancers that may be associated with sitagliptin or exenatide.

Author M. Elashoff states “Use of sitagliptin or exenatide increased the odds ratio for reported pancreatitis 6-fold as compared with other therapies (P<2×10(-16)). Pancreatic cancer was more commonly reported among patients who took sitagliptin or exenatide as compared with other therapies (P<.008, P<9×10(-5)). All other cancers occurred similarly among patients who took sitagliptin compared with other therapies (P=.20).”

If you or a loved one used a GLP-1 therapy drug and suffered from pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation from the manufacturer of the drug in question. For a free, no-obligation case consultation, contact our team of Byetta lawyers, Victoza lawyers, and Januvia lawyers at the information provided below. We have the skills, resources, and experience required to win the justice you and your loved ones deserve.

These findings may show that GLP-1 medications may cause medullary thyroid carcinoma in humans as well. The purpose of a review written by Michael A. Nauck, from the American Diabetes Association was to discuss the evidence in favor and against the hypothesis that GLP-1 based therapies increase the risk of cancer. Author Michael A. Nauck states in his review (titled “Do GLP-1–Based Therapies Increase Cancer Risk?”), “For the purpose of this review, GLP-1–based therapies are GLP-1 receptor agonists such as exenatide, liraglutide, and others or dipeptidyl peptidase-4 (DPP-4) inhibitors such as sitagliptin, vildagliptin, saxagliptin, alogliptin, and linagliptin.”

Nauck writes that most of the available data concluded from studies on this subject have examined exenatide and sitagliptin, and cites that chronic pancreatitis increases the risk for pancreatic cancer approximately 26 fold when compared to people not suffering from chronic pancreatitis. The development of pancreatic cancer can have several influences, such as genetic influences, alcohol abuse, and certain drugs. Nauck further states “Once chronic pancreatitis has been established, chronic inflammation and enhanced intraductal pressure due to stenosis of the pancreatic duct(s) may lead to the development of pancreatic carcinoma.”

It is widely accepted that chronic pancreatitis is associated an elevated risk for pancreatic cancer, but questions still remain about whether or not episodes of acute pancreatitis will have the same negative effects. This is an important question due to the fact that most episodes of pancreatitis are connected with GLP 1 receptor agonist treatment may be episodes of acute pancreatitis. Complicating the findings of studies such as the one described above, the risk of developing pancreatic cancer is twice as high among people who are regular smokers, for smoke from the cigarettes enter the blood and damage the pancreas. Therefore, it is hard to tell if pancreatic cancer observed among smokers came from medications or from smoking.

Nonetheless, many studies have shown that GLP-1 therapy is associated with pancreatitis, and that pancreatitis can lead to pancreatic cancer. Because the manufacturers of many GLP-1 therapy drugs such as Byetta, Victoza, and Januvia have failed to warn users of these risks, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits have been filed.

Author S. Raimondi from the European Institute of Oncology in Milan, Italy, wrote an article titled “Pancreatic Cancer in Chronic Pancreatitis; Aetiology, Incidence, and Early Detection”. Chronic pancreatitis, acute pancreatitis, and pancreatic cancer are primarily responsible for most of the negative effects of exocrine pancreatic disease. The pancreas is a flat gland found in the upper abdomen, behind the stomach. The primary function of this gland is to produce digestive enzymes and hormones that regulate sugar levels in the human body. Chronic pancreatitis may cause severe and life threatening complications and may be associated with an elevated risk for pancreatic cancer.

Raimondi states “Glandular damage from recurrent bouts of acute pancreatitis can lead to irreversible changes characteristic of chronic pancreatitis. In recent decades accumulating evidence has defined longstanding pre-existing chronic pancreatitis as a strong risk factor for pancreatic cancer. The lag period between diagnosis of chronic pancreatitis and pancreatic cancer is usually one or two decades: pancreatitis appearing a year or two before the diagnosis of pancreatic cancer is often the result of tumour-related ductal obstruction.” Rare types of pancreatitis with early onset have the greatest risk factor in developing pancreatic cancer. These types of pancreatitis are hereditary pancreatitis and tropical pancreatitis.

A positive correlation between chronic pancreatitis and pancreatic cancer has been found: about five percent of patients with chronic pancreatitis will develop pancreatic cancer. Screening is the best way for early detection of pancreatic cancer, but development of more sophisticated screening procedures are needed. Before better methods of screening are developed, it is not recommend that patients with chronic pancreatitis be screened.

If you or a loved one used Januvia, Byetta, Victoza, or another GLP-1 therapy drug for type two diabetes and suffered from pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation for the injuries you have sustained by no fault of your own.

For a free, no-obligation case consultation, contact our team of Victoza lawyers, Byetta lawyers, and Januvia lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve.

Some studies and anecdotal reports have shown that pancreatitis may cause an individual to develop, or be at a higher risk to develop pancreatic cancer. Pancreatitis is defined as inflammation in the pancreas. The pancreas produces enzymes that help with digestion as well as produce hormones that regulate the way your body processes sugar. Pancreatitis can appear suddenly and last for a few days, or can inflict an individual for years, this type is called chronic pancreatitis.

While the human body may be able to fight some, mild cases of pancreatitis, chronic pancreatitis may cause serious and often times life threatening complications. There is limited information on this subject, and more research needs to be done to determine the magnitude of the relationship between these two diseases. A multicenter historical cohort study was done by author Albert B. Lowenfels, from the New England Journal of Medicine, titled “Pancreatitis and the Risk of Pancreatic Cancer”, to further explore the relationship between pancreatitis and pancreatic cancer. 2,015 patients with chronic pancreatitis were used for this study. Information was obtained from clinical centers in six countries. From the 2,015 subjects used in this study, 56 cancers were identified, there was a mean follow of 7.4 years. The number of cases of cancer calculated from country specific incidence data was 2.13, which yielded a standardized incidence ratio of 26.3. Data was adjusted for age and sex.

Author Albert B. Lowenfels states “For subjects with a minimum of two or five years of follow-up, the respective standardized incidence ratios were 16.5 (95 percent confidence interval, 11.1 to 23.7) and 14.4 (95 percent confidence interval, 8.5 to 22.8).” Cumulative risk of pancreatic cancer in subjects who were followed for at least 2 years showed a steady increase in pancreatic cancer. 10 and 20 years after being diagnosed of pancreatitis, patients showed 1.8 percent chance of developing pancreatic cancer. People who are diagnosed with chronic pancreatitis have a significantly higher risk of pancreatic cancer, and these findings seem to be independent of sex, country, and type of pancreatitis.

Due to the fact that the manufacturers of many of these drugs have failed to warn of the risk for pancreatitis and pancreatic cancer, a number of Byetta lawsuits, Victoza lawsuits, Januvia lawsuits, and other GLP-1 therapy drug lawsuits have been filed.

If you or a loved one used a GLP-1 therapy drug such as Victoza, Januvia, and Byetta and suffered from either pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation. For more information, please do not hesitate to contact our team of Victoza lawyers, Januvia lawyers, and Byetta lawyers at the information provided below. We have the resources, skills, and experience required to win the justice you deserve, even from the largest of pharmaceutical manufacturers.

Byetta (exenatide) – Renal Failure

Audience: Endocrine and nephrology healthcare professionals

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.

Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).

Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.

Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.